BEUDAMED
    12 results · 33ms · Sources: EU EUDAMED, US FDA

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    SAS SALMONELLA H Z36 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BASE

    FDA UDI
    Nuvasive, Inc.·00887517701770·BASE HL Trial, 12x38x28mm 20°

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690191964·Revision Knee Reamer Spiral Fluted - Zimmer 22mm

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111321·TYING FORCEPS STRAIGHT ROUND TITANIUM

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221118158·3M™ Victory Series™ Second Molar Bands, 955-220...

    Zuma™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981037680·Trial, 32mm x 25mm x 20mm, 8 Deg. Zuma™ Trials ...

    MONOBOND S

    FDA 510(k)
    FDA Class 2 ·Dental

    V-TREND KIT STAPH LATEX TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 11, 2013

    SPL LEAD, TRANSVENOUS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 24, 2014

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013